Fecal Microbiota Transplantation Versus Vancomycin for Primary <i>Clostridioides difficile</i> Infection
Frederik Emil Juul, Michael Bretthauer, Peter Holger Johnsen, Faye Samy, Kristian Tonby, Jan Erik Berdal, Dag Arne Lihaug Hoff, Eirik Hugaas Ofstad, Awet Abraham, Birgitte Seip, Håvard Wiig, Øyvind Bakken Rognstad, Ida Frivold Glad, Jørgen Valeur, Axel E. Nissen-Lie, Eivind Ness‐Jensen, Kristine Marie Aarberg Lund, Linn Skjevling, Kurt Hanevik, Hilde Skudal, Ellen J. Melsom, Raziye Boyar Cetinkaya, Trond J. Cooper, Trond Egil Ranheim, Esben M. Riise, Hans Olov Adami, Mette Kalager, Magnus Løberg, Kjetil Garborg
Abstract
BACKGROUND: infection (CDI), but its role in primary CDI is unclear. OBJECTIVE: To investigate the efficacy and safety of FMT in primary CDI. DESIGN: Randomized, open-label, noninferiority, multicenter trial. (ClinicalTrials.gov: NCT03796650). SETTING: Hospitals and primary care facilities in Norway. PATIENTS: toxin in stool and ≥3 loose stools daily) and no previous CDI within 365 days before enrollment. INTERVENTION: FMT without antibiotic pretreatment versus oral vancomycin, 125 mg 4 times daily for 10 days. MEASUREMENTS: The primary end point was clinical cure (firm stools or <3 bowel movements daily) at day 14 and no disease recurrence within 60 days with the assigned treatment alone. RESULTS: treatment. Clinical cure at day 14 and no recurrence with or without additional treatment was observed in 40 of 51 patients (78.4%) with FMT and 30 of 49 (61.2%) with vancomycin (difference, 17.2 percentage points [95.2% CI, -0.7 to 35.1 percentage points]). No significant differences in adverse events were observed between groups. LIMITATIONS: Open-label design and reliance on clinical end points. CONCLUSION: FMT may be considered as first-line therapy in primary CDI. PRIMARY FUNDING SOURCE: South-East Norway Health Trust.